NCT04793243

Brief Summary

The immunomodulatory effects of vitamin D are known to be beneficial in viral infections, it is also known that its deficiency is associated with a worse prognosis of COVID-19. This study aimed to determine the baseline vitamin D serum concentrations in asymptomatic or mildly symptomatic COVID-19 outpatients, as well as to evaluate the effects of supplementation with 10,00 IU/daily of vitamin D3 and its relationship with biochemical parameters and clinical features.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 3, 2021

Last Update Submit

March 9, 2021

Conditions

Covid19

Keywords

vitamin DLatin Americasupplementation

Outcome Measures

Primary Outcomes (5)

  • Baseline levels of serum vitamin D in COVID-19 patients

    Evaluate serum levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico

    At baseline

  • Correlation between D-dimer and vitamin D serum levels in COVID-19 patients

    Serum levels of D-dimer (ng/mL) will be measured at baseline and correlated with levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico

    At baseline

  • Correlation between transferrin and vitamin D serum levels in COVID-19 patients

    Serum levels of transferrin (mg/dL) will be measured at baseline and correlated with levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico

    At baseline

  • Correlation between ferritin and vitamin D serum levels in COVID-19 patients

    Serum levels of ferritin (ng/mL) will be measured at baseline and correlated with levels of 25(OH)D (ng/mL) in patients with covid-19 from western Mexico

    At baseline

  • Effects of vitamin D3 supplementation on COVID-19 patients

    Serum levels of 25(OH)D (ng/mL) will be determined in the intervention group after 14 days of Vitamin D3 supplementation

    After 14 days of supplementation

Study Arms (2)

Intervention group

EXPERIMENTAL

Formed by 22 patients that received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3

Dietary Supplement: Vitamin D3

Control group

NO INTERVENTION

Formed by 20 patients that did not receive supplementation

Interventions

Vitamin D3DIETARY_SUPPLEMENT

Patients received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intervention group: Patients with positive PCR for COVID-19 of both sexes supplemented with vitamin D
  • Control group: Patients with positive PCR for COVID-19 of both sexes
  • Both groups: Mexican individuals, after signing the informed consent letter and over 18 years of age.

You may not qualify if:

  • Diseases that compromise the absorption of Vitamin D; Crohn's disease, cystic fibrosis, and celiac disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

COVID-19

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • José F Muñoz-Valle, Dr.

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Provost of the University Center of Health Sciences

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 11, 2021

Study Start

August 17, 2020

Primary Completion

October 10, 2020

Study Completion

October 24, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations

ME(1)